The following data is part of a premarket notification filed by Baxter Bentley Laboratories, Inc. with the FDA for Duraflo Ii Heparin Treated Femoral Cannulae Models.
| Device ID | K905312 |
| 510k Number | K905312 |
| Device Name: | DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | BAXTER BENTLEY LABORATORIES, INC. P.O. BOX 19522 Irvine, CA 92713 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible BAXTER BENTLEY LABORATORIES, INC. P.O. BOX 19522 Irvine, CA 92713 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-28 |
| Decision Date | 1991-01-15 |